Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of Depression
|ClinicalTrials.gov Identifier: NCT01516931|
Recruitment Status : Unknown
Verified July 2014 by Huaning Wang, Xijing Hospital.
Recruitment status was: Recruiting
First Posted : January 25, 2012
Last Update Posted : July 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Depression||Procedure: repetitive Transcranial Magnetic Stimulation (rTMS) Behavioral: counseling||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||A Study to Evaluate the Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of the Symptoms of Depression.|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||February 2015|
Experimental: active rTMS and venlafaxine
rTMS：Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months.
Procedure: repetitive Transcranial Magnetic Stimulation (rTMS)
1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks
Placebo Comparator: sham rTMS and venlafaxine
Sham stimulation will be given at the same site and frequency, using a Magstim sham-coil system. During rTMS, participants will be instructed to keep their eyes open and relax.
Placebo monthly by general counseling for 12 months.
Placebo Comparator: venlafaxine alone
responders will be maintained on the same effective dose of venlafaxine for the entire duration of the RCT, unless they relapse and will have to exit the protocol and enter a naturalistic follow-up
- Time for relapse [ Time Frame: Participants will be followed for the duration of 15 month double-blind Relapse Prevention Period, an expected average of 5 weeks ]Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period
- Hamilton Depression Rating Scale [ Time Frame: baseline and 15 months ]Reduction on the scores of HDRS (as on the scores of Depression Scale and Hamilton Anxiety Scale; and improves the global clinical status in Clinical Global Impression, Global Assessment Scale and 36-item Short-form Health Survey - Quality of Life)
- Illness severity change [ Time Frame: baseline and 15 months ]Illness severity change as measured by Clinical Global Impression of Severity for depression.
- subject functioning [ Time Frame: baseline and 15 months ]Change in subject functioning using the Personal and Social Performance Scale (PSP)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516931
|Xi'an, Shaanxi, China, 710032|
|Contact: Qingrong Tan, M.D +086-13991325681 email@example.com|
|Contact: Huaning Wang, Ph.D +086-13609161341 firstname.lastname@example.org|
|Principal Investigator: Qingrong Tan, M.D|
|Sub-Investigator: Huaning Wang, Ph.D|